Monoclonal Antibody Therapy in Treating Patients With Recurrent Hodgkin's Lymphoma

Stanford University

Overview

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have progressive or recurrent Hodgkin's lymphoma.

OBJECTIVES: * Determine the response rate of patients with recurrent Hodgkin's lymphoma treated with monoclonal antibody Hu1D10. * Determine the duration of response and progression-free survival of patients treated with this drug. * Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive monoclonal antibody Hu1D10 IV over 2 hours. Treatment repeats weekly for a total of 4 doses in the absence of disease progression or unacceptable toxicity. Patients are followed at weeks 5 and 8 and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within approximately 12 months.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Lymphoma

Interventions

apolizumabBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin's lymphoma * Progressive or recurrent disease after standard initial therapy * At least 1 unidimensionally measurable lesion (at least 15 mm by conventional techniques) * Patients in first relapse must be ineligible or unwilling to receive high-dose therapy and stem cell transplantation * Evidence of Hu1D10 localization to Reed Sternberg cells by immunohistochemistry * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 6 months Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal Renal * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * HIV negative * No known human anti-human antibody * No prior allergic reaction to compounds of similar chemical or biological composition to monoclonal antibody Hu1D10 * No ongoing or active infection * No other uncontrolled concurrent illness * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * See Chemotherapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Prior second-line (or greater) high-dose therapy and stem cell transplantation allowed Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * No other concurrent investigational agents * No other concurrent anticancer agents or therapies

Locations (1)

Stanford University Medical Center

Stanford, California, United States

Data from ClinicalTrials.gov

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